PRO-TECT SUNSCREEN FOR PROFESSIONALS- meradimate, octinoxate, octisalate, oxybenzone lotion 
Bio-Medical & Pharmaceutical Manufacturing Corporation

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Active ingredients

Meradimate 5.0%

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 5.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn. • if used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

• For external use only. • Do not use on damaged or broken skin. • Stop use and ask a doctor if rash occurs. • When using this product keep out of eyes. Rinse with water to remove.• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure • reapply: after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • children under 6 months: Ask a doctor • Sun protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protections measures including: • limit time in the sun, especially from 10 a.m.-2 p.m. • wear long-sleeved shirts, pants, hats, and sun-glasses

Other Information

• protect this product from excessive heat and direct sun.

Inactive Ingredients

Aloe Vera Leaf, Benzyl Alcohol, C18-36 Acid Glycol Ester, Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked), Cetyl Alcohol, Cetyl Dimethicone 45, Diazolidinyl Urea, Diethanolamine Cetyl Phosphate, dl-Alpha Tocopheryl Acetate, Eicosyl Povidone, Iodopropynyl Butylcarbamate, Lanolin, Mineral Oil, Stearic Acid, Talc, Trolamine, Water.


Questions or Comments

281-835-8051 | Bio-Med & Pharm. Mfg. Corp.

Package label

SUNSCREEN FOR PROFESSIONALS

PRO-SPECTRUM PROCESS BROAD-SPECTRUM UVA/UVB SUNSCREEN

PRO-TECT

Water-Resistant

Fragrance-Free

Aloe & vitamin E

spf 30

PRO-TECT SUNSCREEN FOR PROFESSIONALS 
meradimate, octinoxate, octisalate, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37945-860
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE50 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
LANOLIN (UNII: 7EV65EAW6H)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MINERAL OIL (UNII: T5L8T28FGP)  
TALC (UNII: 7SEV7J4R1U)  
TROLAMINE (UNII: 9O3K93S3TK)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETYL DIMETHICONE 45 (UNII: IK315POC44)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37945-860-64100 g in 1 CONTAINER; Type 0: Not a Combination Product02/05/2015
2NDC:37945-860-65190 g in 1 CONTAINER; Type 0: Not a Combination Product02/05/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/01/1980
Labeler - Bio-Medical & Pharmaceutical Manufacturing Corporation (072186356)
Establishment
NameAddressID/FEIBusiness Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation072186356manufacture(37945-860)

Revised: 12/2023
Document Id: 0c804d58-1443-eee4-e063-6294a90ac65b
Set id: 374e172b-90e8-4fca-8934-dee3ed7b599d
Version: 14
Effective Time: 20231214
 
Bio-Medical & Pharmaceutical Manufacturing Corporation